Strain DSM 11798 reducing trichothecenes in feed (1m01) renewed until 5 April 2036 as Eggerthellaceae instead of Coriobacteriaceae: pour plates on VM agar with Oxyrase, ANI 79.9 % with the closest species — possibly a new taxon; ampicillin MIC of 8 mg/l attributed to the medium
Commission Implementing Regulation (EU) 2026/549, published on 16 March 2026, renews until 5 April 2036 the authorisation of a preparation of the bacterial strain DSM 11798 (isolated from bovine rumen content; applicant BIOMIN GmbH) as a technological additive reducing contamination of feed by trichothecenes for pigs, poultry and ornamental birds, and repeals Regulations (EU) No 1016/2013 and (EU) 2017/930 — although the Polish title of the act speaks of “amending” them and the English one of “repealing”. EFSA (opinion of 20 March 2025) assigned the strain to the family Eggerthellaceae and found the additive still safe; it is a skin and respiratory sensitiser.
- Methods in the annex (the EURL considered the conclusions of the previous assessment still valid, no new report): count of DSM 11798 cells — pour plate method on VM agar supplemented with Oxyrase (enzymatic oxygen removal for an anaerobe); identification — DNA sequencing or PFGE according to CEN/TS 17697. Additive: min. 5 × 10⁹ CFU/g; five batches on average 8.5 × 10¹⁰ CFU/g (6.0 × 10¹⁰–1.1 × 10¹¹). Cadmium, lead, mercury, arsenic, aflatoxins, DON, zearalenone, ochratoxin A, fumonisins, HT-2 and T-2 below the LOQ or LOD; yeasts in one batch 106 CFU/g, moulds 120 CFU/g, Salmonella absent in 25 g.
- Taxonomy: comparison of the genome sequence with 28 reference genomes gave an ANI of 79.9 % with Raoultibacter massiliensis P2849ᵀ, 76.8 % with Eggerthella lenta DSM 2243ᵀ and 73.5 % with Raoultibacter timonensis P3277ᵀ — according to EFSA the strain may be a new taxon within the family Eggerthellaceae; it recommended the name “bacterial strain DSM 11798 of the Eggerthellaceae family”. No resistance genes (CARD, ResFinder) or virulence factors (VFDB) above the thresholds were found.
- Susceptibility (broth microdilution in a strain-specific complex medium): all MICs below the cut-offs except ampicillin — 8 mg/l against 1 mg/l. The control strain Bifidobacterium longum ATCC 15707 also showed elevated ampicillin MICs in the same medium (4 or 16 versus 0.25 or 0.5 mg/l), so EFSA attributes the result to medium interference, but this could not be proven because the strain does not grow on the standard medium. A new in vitro micronucleus test in human lymphocytes (OECD 487, up to 2500 µg/ml) — negative.
- Conditions in the annex: min. 1.7 × 10⁸ CFU/kg complete feed for pigs, poultry and ornamental birds (previously “all avian species”); EFSA confirms safety for piglets, pigs for fattening and all avian species. The additive may only be used in feed that already complies with EU legislation on mycotoxins; simultaneously with narasin/nicarbazin, salinomycin sodium, monensin sodium, robenidine hydrochloride, diclazuril, narasin or nicarbazin. Transitional period: additive and premixtures labelled before 5 October 2026; compound feed before 5 April 2027 (food-producing animals) or 5 April 2028 (others).